While collection bags for incontinent patients are known in the art, such devices have not been free of serious shortcomings. One major problem concerns the formation of an effective external seal about the rectum; various types of adhesive rings have been disclosed but no single design is known for its ease of application and removal, freedom from leakage and unintentional detachment, and adaptability, comformability, and comfort in use. U.S. Pat. Nos. 3,577,989 and 2,491,799 disclose collection bags which are strapped to patients. The manipulation of such straps during attachment and detachment, and the need to move or reposition a patient during such operations, complicates the use of such devices and increases patient inconvenience and discomfort. Devices with adhesive-coated attachment rings, such as disclosed in U.S. Pat. Nos. 3,577,989, 3,734,096, 3,522,807, 3,952,336, and 3,292,626 are also difficult to affix, at least if an effective seal is to be formed, because of the varying contours, and the stretchability, contractability, and softness, of the perianal surfaces. Making adequate sealing contact is only one problem; maintaining such contact is another. If the adhesive used to retain such collectors is aggressive enough to prevent accidental detachment, such collectors may be relatively difficult to remove without causing patient discomfort. Conversely, if a less aggressive adhesive is used to facilitate intentional removal, the possibilities of accidental detachment are increased. In addition, conventional bags are frequently dimensioned and shaped to have inadequate collection capacity or, if of sufficient size, to become twisted and kinked in use, or become wrapped about the leg of a bedridden patient, thereby increasing patient discomfort and the likelihood of accidental detachment.
It is therefore an object of this invention to provide an improved fecal collector which is accommodated comfortably between the legs of a bedridden patient, has relatively large capacity when considered in terms of its length and collapsed dimensions, and has a highly effective attachment ring that is relatively easy to secure in place and, because of its configuration, conformability, and stretchability, is more likely to remain adhered throughout its intended period of use without causing pain or discomfort when intentional removal is undertaken. Another object is to provide a fecal collector having an adhesive-coated attachment ring that is extendable and contractable, thereby reducing shear forces on the adhesive during body movements and producing more uniform distribution of forces on the attachment ring and bag, all with the result that a more effective sealing engagement may be achieved while at the same time utilizing an adhesive that is not unacceptably aggressive. Other features of the bag, such as the location of the attachment ring and its angular relationship to the rest of the bag, the provision of a protected vent to prevent gas buildup, and the pleated construction of the bag, all contribute, along with the extensibility and flexibility of the attachment ring, in preventing concentration of forces in the areas of adhesive attachment that might result in unintended detachment or leakage of the appliance.
The adhesive-coated attachment ring is formed of a soft, pliable, and stretchable closed-cell thermoplastic foam. In an undeformed state, the ring is generally flat and circular in outline with inner and outer margins that are non-concentric. The adhesive-coated surface has four concentrically-arranged portions, namely, a perineal surface portion intended to seal against the perineal area, a coccygeal surface portion, and a pair of relatively large lateral surface portions. All four portions are covered by individually-removable release sheet sections. Sequential removal of such sheets or sheet sections to dispose the respective adhesive-coated surface portions, starting with the perineal portion, then the coccygeal portion, and finally the lateral portions, greatly facilitates complete and effective adhesive attachment of the ring to a patient.
The bag is formed from a single sheet of odor-barrier film folded upon itself with the folded panels then heat-sealed to each other along their free edges. The attachment ring, or at least a liner for that ring, may be heat sealed to the sheet prior to the sealing of the edges of the side panels to form the finished bag. The capacity of the enlongated bag is significantly increased, without increasing the total length of the bag, by pleating at least one of the side panels prior to the final marginal heat sealing operation.
The bag includes both a vent for the escape of gases and a passage for the insertion of a thermometer or other instrument into the interior of the bag and into direct contact with a patient. It has been found that the passage and vent may be easily and effectively formed by providing each side panel of the bag with a flap or tab portion, then folding such flap portions reversely inwardly into contiguous relation to form a pair of adjacent pockets when the panels are finally heat sealed together and, just before the heat sealing operation, inserting a resilient foam pad into at least one of the pockets. The self-closing passage leading into the interior of the finished bag extends between the contiguous infolded flaps of the pockets. The vent for the escape of gases takes the form of one or more pinholes formed in the wall of a pocket containing the foam pad.
Other features, objects, and advantages of the invention will become apparent from the specification and drawings.